Multiple Myeloma
Conditions
Interventions
Denosumab in normal renal function:Denosumab
Zoledronic acid in normal renal function:Zoledronic acid
Denosumab in abnormal renal function:Denosumab
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged >= 18 years; 2. Confirmed newly diagnosed MM patients; 3. At least one osteolytic change; 4. Main organ functions are normal: serum ALT and AST = 3 months; 7. Provide written informed consent, understand and follow the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Uncontrolled systemic fungal, bacterial or viral infection (defined as the symptoms/signs at that time related to the infection and no improvement despite the use of antibiotics or other treatment); 3. Known or suspected hypersensitivity to desudumab; 4. Known active viral infection of human immunodeficiency virus (HIV) or hepatitis B or C; 5. Have a clear history of neurological or mental disorders, including epilepsy or dementia; 6. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study; 7. Use other test drugs at the same time or participate in clinical trials of other drugs one month before the test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first Skeletal Related Event (SRE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Three items of bone metabolism;progression-free survival, PFS;overall survival, OS;overall response rate, ORR;Renal remission rate; | — |
Countries
China
Contacts
Public ContactRong Fu
Tianjin Medical University General Hospital
Outcome results
None listed